MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional, report with the FDA on 2019-01-22 for ZELTIQ COOLCORE APPLICATOR BRZ-AP1-063-000 manufactured by Zeltiq Aesthetics, Inc..
[133764071]
The reported elevated crp, severe abdominal pain, generalized rashes, weakness and fatigue were collectively assessed as a serious injury due to the report that this constellation of symptoms has caused the patient to be bed-ridden. A direct causal relationship between the patient's condition and the use of the coolsculpting device has not been established, but due to the temporal relationship of the onset of events occurring after treatment, it is possible that coolsculpting may have contributed to the patient's condition. Allergan has "dilligently" attempted to gather additional device information, but no further information was received. Zeltiq (now allergan) was initially made of the reportable event on 02/02/2018, and an initial attempt to submit this mdr was "nade" on 04/20/2018. However due to transmission issues, this mdr is being re-submitted. Cdrh was notified on 12/21/2018 and has assigned ticket number (b)(4) for this issue.
Patient Sequence No: 1, Text Type: N, H10
[133764072]
On 02/02/2018 allergan was made aware that a (b)(6) female patient, who received 2 cycles of coolsculpting treatment on (b)(6) 2016 to the lower abdomen using the coolcore applicator and 2 cycles to the flanks using the coolcurve applicator, became bed-ridden due to symptoms of severe abdominal pain starting six weeks after treatment, followed by a generalized rash, fatigue, weakness, hot flashes, sweating, and elevated c-reactive protein (crp). The patient's crp was reported to have been in the low 40 range, and the baseline crp level was not provided. The patient stated she had consulted 17 physicians, but no definite diagnosis has been provided. Allergan has diligently attempted to gather additional information on the device used, patient's diagnosis, treatment information, and patient's current status, but no further information was available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007215625-2018-00005 |
| MDR Report Key | 8267775 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2019-01-22 |
| Date of Report | 2019-01-21 |
| Date of Event | 2016-05-13 |
| Date Mfgr Received | 2018-02-02 |
| Date Added to Maude | 2019-01-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JENNIFER CLETO |
| Manufacturer Street | 4410 ROSEWOOD DRIVE |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal | 94588 |
| Manufacturer Phone | 9256214130 |
| Manufacturer G1 | ZELTIQ AESTHETICS, INC. |
| Manufacturer Street | 4410 ROSEWOOD DRIVE |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94588 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZELTIQ COOLCORE APPLICATOR |
| Generic Name | ZELTIQ COOLCORE APPLICATOR |
| Product Code | OOK |
| Date Received | 2019-01-22 |
| Model Number | BRZ-AP1-063-000 |
| Catalog Number | BRZ-AP1-063-000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZELTIQ AESTHETICS, INC. |
| Manufacturer Address | 4410 ROSEWOOD DRIVE PLEASANTON CA 94588 US 94588 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-01-22 |